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Ukugunyazwa kwe-WHO-LYHER Novel Coronavirus (COVID-19) Antigen Test Kit

Ngomhla ziyi-10 kuJulayi, i-LYHER Novel Coronavirus(COVID-19)Ikhithi Yokuhlola I-Antigen(Colloidal Gold) isohlwini lwe-WHO EUL, okuwukuqashelwa kwesistimu yokukhiqiza ye-Laihe kanye nokuqinisekiswa kwekhwalithi, futhi ikhuthaza kakhulu ukuzethemba kukaLaihe ngokuqhubeka nokubeka umkhakha wokuhlola ngokushesha izifo zegciwane lokuphefumula.

U-Laihe uzibophezele ekubeni uchwepheshe wesixazululo esiphelele sama-reagents okuxilongwa ngokushesha kwezifo zokuphefumula, futhi i-matrix yemikhiqizo yokuhlola okusheshayo yokuphefumula ithuthukiswa kancane kancane. Ngaphezu kwemikhiqizo ye-COVID-19, uLaihe uphinde wathola nezitifiketi zokubhalisa ze-EU CE zeminye imikhiqizo eminingi yokuphefumula, efana ne-LYHER COVID-19 kanye nekhithi yokuhlola i-Influenza A/B Antigen ukuze azihlolele yona, i-Respiratory Multiple Rapid Test (COVID-19/) FluA/FluB/RSV/Adeno) nokunye. Ukuhlolwa okusheshayo komkhuhlane, i-RSV, i-parainfluea, i-rhinovirus, i-adenovirus, i-streptococci nezinye izifo ezihlobene nokuphefumula nakho kusenqubweni yokugqugquzela ukufakwa kwe-IVDR kanye nokubhaliswa kwe-WHO.

WHO EUL产品清单SARS-CoV-2_Approved_IVDs-1
WHO通过信 23 07 11 IP 23 07 10 EUL 0603-226-00 EUL complete and listing_df_页面_1

Isikhathi sokuthumela:Jul-18-2023
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